Integrated Devices: A New Regulatory Pathway to Promote Revolutionary Innovation

Abstract

Policy Points Current medical device regulatory frameworks date back half a century and are ill suited for the next generation of medical devices that involve a significant software component. Existing Food and Drug Administration efforts are insufficient because of a lack of statutory authority, whereas international examples offer lessons for improving and harmonizing domestic medical device regulatory policy. A voluntary alternative pathway built upon two‐stage review with individual component review followed by holistic review for integrated devices would provide regulators with new tools to address a changing medical device marketplace